Teva v. Astrazeneca: Invalidating a patent with secret prior art

"Secret" prior art is prior art that is not available to the public as of the date of invention for the relevant patent. The most well-known category of secret prior art is that of pre-publication patent applications. 35 U.S.C. 102(e). Less commonly asserted is prior invention by another under 102(g)(2). This case illustrates the strength of such prior art under the current novelty framework.

Teva, the owner of Patent No. RE39,502, sued AstraZeneca, asserting that an AstraZeneca drug (CRESTOR) infringed several claims of the '502 patent covering a pharmaceutical formulation stabilized exclusively by an amido-group containing polymeric compound ("AGCP compound"). The problem Teva faced was that AstraZeneca had made the first batches of its drug in the summer of 1999, prior to Teva's asserted invention date of December 1999. Given this prior invention by AstraZeneca, the district court granted summary judgment of anticipation under 102(g)(2). Teva appealed.

Teva's principal argument on appeal was that because AstraZeneca had failed to appreciate the stabilizing role the AGCP compound played in its drug product in 1999, it had not conceived of – and therefore not made – the invention as required by 102(g)(2). This argument rested on the undisputed fact that although AstraZeneca's drug contained an AGCP compound, it was designed to use a non-AGCP compound as the stabilizer; the AGCP compound was believed to be a disintegrant.

Note: Because both the product that Teva accused of infringing and the 1999 batches were the same formulation, AstraZeneca conceded infringement for purposes of its motion for summary judgment of invalidity. In other words, it was undisputed that the AGCP compound was acting as the exclusive stabilizer even if AstraZeneca was unaware of that fact in 1999.

Conception requires an appreciation of what is made, not why it works: Rejecting Teva's argument, the panel concluded that AstraZeneca had met the requirement for conception of its prior invention by appreciating "that the compound it created was stable and what the components of the formulation were." Slip Op. at 12. AstraZeneca did not need to appreciate which component was responsible for the stabilization or why the invention worked.

The "invention" as distinct from the claims for purposes of 102(g): In arriving at its ultimate conclusion of anticipation, the court drew a distinction between the "invention" and the claims, at least for purposes of 102(g). Traditionally, an anticipation analysis involves first establishing that something is prior art and then demonstrating that this prior art contains all the elements of the claimed invention either expressly or inherently. Under a conventional approach to anticipation, then, Teva's claims would be invalid once the prior art status of AstraZeneca's 1999 batches was established since there was no dispute that the batches met all the limitations of Teva's claims.

Section 102(g) operates somewhat differently, however, due to its origins in the interference context. It requires that another inventor have made "the invention" that is at issue. To address this issue, the court in Teva invoked a broad view of what constitutes the "invention" that allowed it to conclude that AstraZeneca had conceived of the same invention as Teva despite AstraZeneca's failure to think of it in the claimed terms. Quoting from Dow Chemical Co. v. Astrao-Valcour, Inc., 267 F.3d 1334 (Fed. Cir. 2001), the court applied a concept of the "invention" as distinct from the claims. "The invention is not the language of the [claim] but the subject matter thereby defined." Slip Op. at 12, quoting Dow (quoting Silvestri v. Grant, 496 F.2d 593, 597, 599 (CCPA 1974)). “The language of the count is but one way to define the new form and certainly not a unique definition [. . . and a]ny claim they might have written, based on this or other information specific to [the new form] would still define the same subject matter as the count even though in different terms.” Slip Op. at 9, quoting Silvestri at 601 (CCPA 1974)). “[T]hat which we call a rose [b]y any other name would smell as sweet.” Slip Op. at 9, quoting William Shakespeare, Romeo and Juliette act 2, sc. 2. Based on this view of the "invention" as a metaphysical entity existing independent of any defining claim language, the court held that AstraZeneca had conceived of Teva's invention, despite doing so in different terms than Teva chose to use in the patent claims.

The Impact of the AIA: With the change to a first-to-file-or-first-to-disclose system, the America Invents Act eliminates 102(g)(2) prior art. The impact of this change is significant in cases such as this one: under the future 102, AstraZeneca would not have been able to bring this validity challenge. Nor is it probable that AstraZeneca could seek protection under the framework of prior user rights: even if its batches met the requirement of being a composition of matter used in a commercial process (there's a strong argument they would not), AstraZeneca's manufacture began less than one year before the filing date of Teva's provisional patent application.

Correction: The first sentence of the original version of this post referred to secret art as art that is unavailable to the public as of the patent's priority date. That is incorrect. Secret prior art is prior art that is unavailable to the public as of the invention date for the patent (the relevant date for purposes of 102(e), (f), and (g)).

Addendum: Several of the comments have pointed to the sentence in the court's opinion that says "By late summer 1999, AstraZeneca had disclosed the ingredients and quantities for its rosuvastatin formulation matching those of all commercial drug dosage strengths," and pointed out that this implies that AstraZeneca's formulation was publicly disclosed prior to Teva's invention date. The court's use of "disclosure," however, appears to just be an unfortunate word choice. According to AstraZeneca's brief, the only relevant events that took place during that time period were the manufacture of the batches and an internal company presentation on the finalized sales formulation of the tablets. Any form of public disclosure took place much later, such as through its patents and applications, the first of which was filed in Great Britain on January 26, 2000.

I thought that secret prior art is routinely used to invalidate patents. Back in the 1990s, we would often go search the radio equipment on decommissioned U.S. submarines for art invaliating MOSFETs and other CMOS technology. The technology was classified for several decades and often antedated the patents at issue.

I understand that what is essentially being protected in first or second medical use claims is the notice in the packaging, and the entry in the Blue Book, or Red Book, or whatever the doctors in your country use for selecting a drug.

Under the EPC, the doctor could still prescribe you the same active ingredient from a competing manufacturer for treating your exotic disease, but off-label. She is protected in that by Article 53(c) EPC, but the health and liability insurance systems would certainly make it more difficult.

I would nevertheless venture to say that, in my opinion, the above “use” claim does not fall under the scope of Article 54(4), as the “use” in question is for “stabilizing”, and not related to the disease itself.

The practice at the EPO is to interpret the expression “for” to be synonymous with “suitable for”, when it’s not dealing with Art. 54(4) EPC. If a piece of prior art discloses an element providing an effect A, but is otherwise suitable (without modification) for the claimed effect B, then the reference is novelty destroying. This is also in line with the PSA, where the examiner can define an objective problem differing from the one purportedly solved by the invention.

Some national courts in Europe, however, do not follow this approach, and use a stricter test I’d dub “inventive novelty” – the reference must disclosed the application mentioned in the claim. I understand that SCOTUS too is narrower in its interpretation of claims. Busting a patent at the EPO is therefore preferable than arguing with the TGI in Paris.

There used to be a prohibition on patents for medications in many EPC member states, and a form of claim was developed in Switzerland to circumvent it. Swiss type claims have a formulation of the form: “Use of compound X in the preparation of a medicament for the treatment of disease Y”.

This form is now deprecated. It was only tolerated, as it was not considered to comply with the EPC in other aspects, if I understand correctly.

EPC 2000 did away with all that, Article 54(4) EPC 2000 now explicitly allows the patenting of known products for the treatment of specific medical conditions.

I understand that what is essentially being protected in first or second medical use claims is the notice in the packaging, and the entry in the Blue Book, or Red Book, or whatever the doctors in your country use for selecting a drug.

Under the EPC, the doctor could still prescribe you the same active ingredient from a competing manufacturer for treating your exotic disease, but off-label. She is protected in that by Article 53(c) EPC, but the health and liability insurance systems would certainly make it more difficult.

My experience in pharma is mostly as a former patient, so a “real” specialist might find some nits to pick in the above.

Roufousse reports that the patent family EPO claim is NOT a use claim.

Sorry, I tried to mention this in my first comment, but with all the trouble typepad gave me this bit fell through the cracks. (I have no idea what exactly in my writing it finds unpleasant. The links? The formatting? The highlighting?).

I should have added that the extraneous requests the applicant made in reply to the communication according to Rule 71(3) did try to introduce a use claim:

29. Use of a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof for stabilizing an active component in a composition for the treatment of dyslipidemia comprising, as an active component, at least one ring-opened 7-substituted-3,5- dihydroxyheptanoic acid or ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or a pharmaceutically acceptable acid salt thereof; wherein said composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers;
wherein the at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, comprises between 10 and 99 percent by weight of the composition, and wherein an aqueous dispersion of said composition exhibits a pH of 6.5 to 8 when measured on said composition when disintegrated in deionised water at a concentration of active component of 1 mg/ml.

This claim is now part of the “divisional” application. I don’t see a written opinion, it appears that the applicant should expect a direct grant (the invention is essentially the same as in the “parent” application, but expressed in a “use” claim), but there should be a piece of paper somewhere that says that nothing is being objected to.

LP, I don’t know what this case has to do with functional claiming, because if I understand the facts correctly, the defendant not only knew the composition of the accused product and how to make it, they also knew that it worked. They just did not know why it worked.

Because they can describe what the composition is in terms of its structure or composition, and/or how to make it, I don’t understand how one can leap from this into saying that one can claim a composition in terms of what it does. This case does not support that proposition whatsoever.

Sounds like a great argument to use against those anti-software people who constantly chirp against functional claiming and want only a detailed structural recitation in the claims…

Likewise,…

“The court likewise reaffirmed that § 102(g) “does not require that [a prior inventor] establish that he recognized the invention in the same terms as those recited in the count [because t]he invention is not the language of the count but the subject matter thereby defined.” Id. (quoting Silvestri v. Grant, 496 F.2d 593, 597, 599 (CCPA 1974)). As Silvestri had explained, “the language of the count is but one way to define the new form and certainly not a unique definition [. . . and a]ny claim they might have written, based on this or other information specific to [the new form] would still define the same subject matter as the count even though in different terms.” 496 F.2d at 601. See also In re Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011) (“The claimed subject matter is not presumed to change as a function of how one elects to measure it.”); William Shakespeare, Romeo and Juliette act 2, sc. 2 (“[T]hat which we call a rose [b]y any other name would smell as sweet.”).

It doth appear that those who want to diminish functional claiming do not have legs to stand upon.

MM, you assume right. How could AZ be intruding on the given exclusive right, deliberately using AGCP as a stabilizer, when the fact was that they had no inkling that AGCP was a stabilizer.

Teva made a new useful and non-obvious contribution to the art by reporting to the public AGCP’s effectivemess as a stabilizer. So, give that man TEVA a patent and, watch out, anybody he from now on catches deliberately using AGCP as a stabilizer.

Course, TEVA has the burden, and might find it hard to prove infringement. But that’s a task they brought on themselves, by adopting a “use” form of claim. Roufousse reports that the patent family EPO claim is NOT a use claim. I think we know why. But, in other fact matrices, a “use” claim might be quite fruity.

Rouf, I think our chat on the IPKat has receded into history. I doubt anybody will notice, if you post anything to that thread now.

MD On the facts of the case, there might be room in Europe for a valid claim along the schematic lines of:

Use of AGCP as a stabiliser in a drug composition.

Refresh my memory, Max: if other entities were previously using AGCP in drug compositions for non-stabilizing purposes (but were unaware that AGCP was, in fact, also acting as a stabilizer in those compositions), are these entities immune from infringement (assume that they change nothing in their compositions)? I assume they must be. Another way to put the question would be: if a composition has multiple uses (e.g., it’s a buffer, it prevents headaches, and it sweetens the formula) but only of the uses is “new”, can one avoid infringement of a novel “use claim” simply by avoiding any reference in its advertising/labelling to the patented use?

I have a secret Weapon… I suggest we get some real Duds, leaking out the information, claiming the Ideas are Awesome here in the States… then let them steal the Ideas and do it all manufacture, ship and then try to sell them HAHAHAHA.

1. A stabilized pharmaceutical composition for use in the treatment of dyslipidemia,
comprising, as an active component, at least one ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or a pharmaceutically acceptable acid salt thereof,
and a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof; wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers; wherein the at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, comprises between 10 and 99 percent by weight of the composition, and wherein an aqueous dispersion of said composition exhibits a pH of 6.5 to 8 when measured on said composition when disintegrated in deionized water at a concentration of active component of 1 mg/ml.

Claim 1 of US-RE:

1. A stabilized pharmaceutical composition for the treatment of dyslipidemia,
comprising an active component consisting essentially of one or more compounds selected from the group consisting of (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof,
and (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof,
and a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.

The USRE claim ends in a disclaimer, whereas the EPB1 claim describes the stabilizer in more (relevant?) detail.

There is also wording concerning the “HMG-CoA reductase inhibiting”, which this pharma layman can’t really assess (I think it’s not that relevant, though). The potential EP OPPO to come could be instructive, if you’re patient enough. (Is the 102 prior art eligible under 54(2)?)

The applicant tried to get the case reopened after the conclusion of the OP during which a few requests had been rejected. The ED grumbled, and the new requests were withdrawn. But a “divisional” had been filed in due time, so it’s not really a problem. This reminds me of the discussion of last week at IPKat to which I haven’t returned yet. (There’s many new comments I haven’t read yet).

The grant was mentioned on 14.09.2011 in the EP Bulletin, and can be asserted from that day onwards. We’ll have to wait until 14.06.2012 to see who will oppose this patent, and with what arguments.

” “The invention is not the language of the [claim] but the subject matter thereby defined.” ”

JD chuckled I’m sure.

“”The invention is not the language of the [claim] but the subject matter thereby defined.” Slip Op. at 12, quoting Dow (quoting Silvestri v. Grant, 496 F.2d 593, 597, 599 (CCPA 1974)). “The language of the count is but one way to define the new form and certainly not a unique definition [. . . and a]ny claim they might have written, based on this or other information specific to [the new form] would still define the same subject matter as the count even though in different terms.” Slip Op. at 9, quoting Silvestri at 601 (CCPA 1974)). “[T]hat which we call a rose [b]y any other name would smell as sweet.” Slip Op. at 9, quoting William Shakespeare, Romeo and Juliette act 2, sc. 2. Based on this view of the “invention” as a metaphysical entity existing independent of any defining claim language, the court held that AstraZeneca had conceived of Teva’s invention, despite doing so in different terms than Teva chose to use in the patent claims.

”

Iirc I used the same passage from shakespeare when discussing this issue with ol JD a few years ago.

Don’t worry Ned. China already adopted the EPC, more or less lock, stock and barrel. It just has to get round to the EPO Problem and Solution Approach for deciding what was obvious. All in the fullness of time, I’m sure.

Good question! I was wondering myself if a non-publication request could create gprior art as of the application filing date stayin in secret for years – prior art not discoverable until when, many years later, a patent finally issues on that application or its continuation or divisional?

Very helpful analysis, Jason. The AIA context in this post and discussion are especially welcome and helpful.

One might think that analyzing current CAFC opinions is little more than pocket-pulling, but Section 3(n) of the AIA sets the effective date for the new 102 at Mar16.2013 — for all applications filed on or after that date.

And so there is not going to be a “switch-over” day as far as the case law goes. “Old 102″ case law like this case will still be applicable until about 2033, or 20 years after the last “old 102″ application is filed on Mar15.2013.

Although prosecutors will find some immediate relief on Mar16.2013, the litigators will have to do overtime to analyze both pre and post AIA statutes for 20 years.

Your opinion, not mine, Ned. I don’t assume ANYTHING when it comes to interpreting the AIA, and especially, how it’s “convulted” Section 3 will be construed. Too many “language landmines” to diffuse there.

Reading this thread reminds me of EPC “use” claims. On the facts of the case, there might be room in Europe for a valid claim along the schematic lines of:

Use of AGCP as a stabiliser in a drug composition.

So, I wonder if there is a European counterpart to this litigation, in which the relevant claim is plainly valid but AZ plainly does not infringe it.

Of course I realise that a counterpart action in Europe is not of interest to readers here. But now that the USA has harmonised with the EPC, I wonder what the result might have been, if the American litigation were taking place 20 years after implementation of the AIA.

“And also note that the “future 103″ still says “prior art” without saying that “prior art” has to be one of the barring acts described in the “future 102.” Old 102(g)(2) may still be alive and well, even in view of the AIA.”

Nice try. I don’t think so. What I think will happen in the future is that prior art will be limited to subject matter that is “publicly accessible,” with prior patent applications being the sole exception.

Here it appears that Cisco had proven prior invention, it just not could not identify exactly who made the invention. That was fatal to Cisco, but seems ridiculous on its face. The exact identity of an inventor seems irrelevant so long as it is clear that the invention was made in United States prior to the invention by the patentee.

The court seems to be saying that functional limitations need not be disclosed in a prior art reference if all structural limitations are and the function is inherent. That’s not exactly a shocker. Similarly, a defendant could not claim they did not infringe because they did not appreciate the stabilizing function of the additive.

Really, the case conforms to the old axiom, “that which infringes if later, anticipates if earlier.”

Thanks for noting the transititional provisions under “future 102(d)”, Paul. But as I note above, I wouldn’t assume that deletion of “old 102(g)” necessarily means that “secret” prior art couldn’t be asserted under “future 103,” even if it amounts to anticipation, not just obviousness. Again, “future 103″ still says “prior art,” not barring activities under “future 102″ that don’t quite show all of the claimed invention. Not until the courts say otherwise when they construe “future 103″.

There will still be some secret prior art under the AIA – for pre-publication patent applications – if I’m reading the following sub-section of AIA 102 correctly:
“(d) Patents and Published Applications Effective as Prior Art- For purposes of determining whether a patent or application for patent is prior art to a claimed invention under subsection (a)(2), such patent or application shall be considered to have been effectively filed, with respect to any subject matter described in the patent or application–
(1) if paragraph (2) does not apply [the prior public disclosure by another inventor one year grace period], as of the actual filing date of the patent or the application for patent; or
(2) if the patent or application for patent is entitled to claim a right of priority under section 119, 365(a), or 365(b), or to claim the benefit of an earlier filing date under section 120, 121, or 365(c), based upon 1 or more prior filed applications for patent, as of the filing date of the earliest such application that describes the subject matter.”
[But the AIA did expressly remove 102(g) and any other reference to “invention dates” in the 102 definitions of what is prior art, and elsewhere. The only other possible “secret” prior art and/or prior invention situation under the AIA [if you want to call it that] that I am aware of, is someone secretly holding a good fact situation for a “derivation” case against an application or patent of another. But that will require a more proof than just a prior alleged invention date.]

“With the change to a first-to-file-or-first-to-disclose system, the America Invents Act eliminates 102(g)(2) prior art. The impact of this change is significant in cases such as this one: under the future 102, AstraZeneca would not have been able to bring this validity challenge.”

Not necessarily true. The “future 102″ of the AIA (the Abominable Inane Act) bars patenting if the claimed invention was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” AstraZeneca could still assert the evidence of it’s late summer-1999 CRESTOR formulation (which is characterized in the Federal Circuit opinion as being “disclosed”) under the “future 102″ as either “public use” or at least “otherwise available to the public” which would be prior to Teva Pharmaceuticals earliest effective filing date (i.e., the proviisional filing date of April 2000). And also note that the “future 103″ still says “prior art” without saying that “prior art” has to be one of the barring acts described in the “future 102.” Old 102(g)(2) may still be alive and well, even in view of the AIA.

By “secret” prior art, I’m referring to is prior art that is not available to the public as of the date of invention. It is ultimately disclosed to the public – just at a later date than the date of invention.

In this case, AstraZeneca’s formulation was not publicly disclosed until after December 1999, Teva’s asserted date of invention. Yes, the opinion does say “By late summer 1999, AstraZeneca had disclosed the ingredients and quantities for its rosuvastatin formulation matching those of all commercial drug dosage strengths,” but that appears to be sloppy drafting. According to AstraZeneca’s brief, the only relevant events that took place during that time period were the manufacture of the batches and an internal company presentation on the finalized sales formulation of the tablets.

Public disclosure took place later – through patent applications, with the first filed in Great Britain on January 26, 2000. (Note with the addition of the filing date fact, AstraZeneca could have prevailed under the new 102 because its patent would constitute 102(a)(2) art.)

See my 2:05 am comment below for more details. The answer is that the prior invention wasn’t really “secret”, although the property recited in Teva’s claims was not publicly known prior to Teva’s provisional application. Personally, I wouldn’t refer to this as “secret prior art” case.

If those 1999 batches were sold or otherwise made public, then not necessarily “secret prior art”.

True enough. And the term “secret” doesn’t appear in the case (or in the statute). In this case, the composition at issue was publicly known to have been used by the defendant in one of its compositions a few months before the earliest invention date of the patentee (December 1999) (“By late summer 1999, AstraZeneca had disclosed the ingredients and quantities for its rosuvastatin formulation matching those of all commercial drug dosage strengths.”)

What this issue of “had not abandoned, suppressed, or concealed it” raised in the case?

It was raised by Teva but it was correctly swatted away by the court as a moot issue, given Teva’s infringement allegations.

The key fact:

Because AstraZeneca conceded infringement for the limited purpose of its summary judgment motion, and because Teva maintains the allegation of infringement upon which its suit is based, it is undisputed for the purpose of this appeal that AstraZeneca’s drug is an embodiment within the scope of the asserted claims. See Evans Cooling Sys., Inc. v. Gen. Motors Corp., 125 F.3d 1448, 1451 (Fed. Cir. 1997) (“Although [defendant] bore the burden of proving that the [asserted prior art/accused product] embodied the patented invention or rendered it obvious for purposes of the summary judgment motion, this burden is met by [plaintiff’s] allegation, forming the sole basis for the complaint, that the [asserted prior art/accused product] infringes.”).

Nice. I’m hoping that more defendants take similar approaches with 101 defenses. You’re accusing me of thinking a new thought while practicing the prior art? If so, you are effectively claiming the new thought. You still want to say that I’m infringing? Fine. 101 kills your patent dead. Have fun at the funeral.

“By late summer 1999, AstraZeneca had disclosed the ingredi-ents and quantities for its rosuvastatin formulation matching those of all commercial drug dosage strengths. On the basis of these undisputed facts, the district court found that “there is no genuine issue of material fact as to whether AstraZeneca arrived at the same [AstraZeneca drug] product formulations that Teva accuses of infringe-ment—and made batches of those formulations—before Teva conceived of or reduced to practice the subject mat-ter of the ’502 patent.””

How exactly was this “secret” prior art? The asserted patent has an earliest priority date almost a year after AZ’s disclosure.

Awesome execution by the defendant here. Even more impressive would have been an invalidation of the patent as obvious using the same secret prior art. We can’t have everything, though. Here’s hoping some defendant pulls off that feat before the new rules take effect!